NSCLC Stage IV Clinical Trial
Official title:
Optimizing the Therapeutic Dose of Apatinib Mesylate Tablets in Patients With Lung Cancer by Dose Titration:A Real World Exploratory Study
NCT number | NCT03594682 |
Other study ID # | HB-B001 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2018 |
Est. completion date | July 2020 |
Verified date | June 2018 |
Source | Beijing Chest Hospital |
Contact | Hu Ying |
Phone | 010-89509330 |
huying2004[@]126.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to evaluate the safety and efficacy of two different administration methods of apatinib in NSCLC patients.
Status | Not yet recruiting |
Enrollment | 31 |
Est. completion date | July 2020 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Aged =18; 2. Locally advanced/metastatic non-small lung cancer (IIIb / IV) confirmed by pathology with measurable lesions ; 3. Patients with wild type EGFR/ALK must received two kinds of systemic chemotherapy before;Patients with EGFR mutation positive had experienced treatment failure with TKI in first line and Chemotherapy in second line ; 4. ECOG:0-4; 5. The subjects were treated with other drugs has been restored (NCI CTCAE version 4.0 class 1 or less), which accept nitroso urea or mitomycin interval 6 weeks or more; Accept other cytotoxic drugs, bevacizumab (Avastin) (except local palliative radiotherapy), radiotherapy or surgery four weeks or more. EGFR TKI =2 weeks; Main organs function is normal; 6. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib; 7. Patients voluntarily entered the study and signed informed consent form (ICF). Exclusion Criteria: 1. brain MRI, CT or venography confirmed that there are brain hemorrhage symptoms; 2. Tumor invade big vessels or close to big vessels (less than 5mm); 3. Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy).; 4. Patients with with grade ? myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male = 450 ms, female =470 ms); 5. Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy 6. Urine protein=++, or urine protein in 24 hours=1.0g 7. CTCAE 2 degrees or more peripheral neuropathy, except the trauma; 8. Unhealed bone fracture or wound for long time; 9. Patients who received systemic antibiotic treatment of serious infections; 10. Decompensated diabetes or high dose of glucocorticoid treatment other banned disease; 11. Patients with active hepatitis B virus or hepatitis c virus infection; 12. Patients with obvious factors affecting absorption of oral drugs, such as difficulties in swallowing, chronic diarrhea and intestinal obstruction, etc. 13. Received big surgery, had bone fracture or ulcer in 4 weeks. 14. Within 6 weeks before random severe weight loss (> 10%); 15. Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc; 16. Random 12 months before the artery/vein thrombosis events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; 17. Known history of hypersensitivity to apatinib or any of it components. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Beijing Chest Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | duration of treatment | time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib | two years |
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